Comparative effectiveness of pelvic floor muscle training, Mirabegron, and Trospium among older women with urgency urinary incontinence and high fall risk: a feasibility randomized clinical study.

盆底肌肉训练、米拉贝隆和曲司氯胺对患有急迫性尿失禁和高跌倒风险的老年女性的效果比较：一项可行性随机临床研究。

• 批准号: 10648299
• 负责人: Steven R Fisher
• 金额: $ 23.32万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10648299
• 关键词: Accidents; Adherence; Adverse event; Agonist; Anti-Cholinergics; Behavior Therapy; Behavioral; Centers for Disease Control and Prevention (U.S.); Cessation of life; Characteristics; Chlorides; Clinic; Clinical; Clinical Research; Clinical Trials; Cognition; Data; Decision Making; Development; Educational Intervention; Effectiveness of Interventions; Elderly; Enrollment; Equipoise; Evaluable Disease; Failure; Geriatrics; Head; High Risk Woman; Home; Impairment; Incontinence; Individual; Intervention; Interview; Link; Literature; Measures; Mediation; Medical; Methods; Muscarinics; Outcome; Overactive Bladder; Participant; Patients; Pelvic Floor Muscle; Pharmaceutical Preparations; Pharmacological Treatment; Physical Function; Physical activity; Physicians; Pilot Projects; Prevalence; Productivity; Quality of life; Randomized; Research; Research Design; Risk Factors; Sampling; Screening procedure; Severities; Social isolation; Stigmatization; Structure; Symptoms; Syndrome; Texas; Theoretical model; Titrations; Training; Treatment Cost; Universities; Urinary Incontinence; Variant; Visit; Woman; Work; arm; care seeking; cholinergic; clinical efficacy; comparative; comparative effectiveness; comparative effectiveness trial; comparative efficacy; design; experience; fall injury; fall risk; falls; fear of falling; high risk; micturition urgency; multiple chronic conditions; older women; patient population; pharmacologic; physical therapist; primary outcome; programs; randomized effectiveness trial; recruit; risk sharing; side effect; success; treatment response; treatment risk; trial comparing; urinary

ABSTRACT Untreated, urinary urgency and incontinence can precipitate a vicious cycle of decreasing physical activity, social isolation, fear-of-falling, and falls. The urge to urinate frequently can also limit physical activity - concern for finding oneself too far from a bathroom can be a powerful motivator for just staying home. Structured behavioral interventions or medications are common initial treatment options. But they elicit their effects through very different mechanisms of action that may influence fall related outcomes differently. There is, however, a critical lack of direct head-to-head trial evidence on non-pharmacologic and pharmacologic treatments for urgency urinary incontinence (UUI), particularly in women with co-existing fall risk. The proposed feasibility pilot study is a randomized, multi-arm, mixed methods, clinical trial comparing three currently in use initial treatment options for older women: i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride, in women 65 and older with UUI or overactive bladder (OAB) who also screen positive for increased risk of falling. Mirabegron and Trospium are not associated with longitudinal effects on cognition that the traditionally used anticholinergic mediations have recently been linked to. Our Specific Aims are 1) Conduct a pilot study in clinical settings to determine the feasibility of enrolling older women with UUI or OAB who are at high risk of falling in a three-arm (PFMT, vs. mirabegron vs. Trospium), randomized comparative effectiveness trial; 2) Characterize outcomes across the three interventions; and 3) Qualitatively explore perceived factors influencing the non- pharmacologic and pharmacologic treatment experience in these patients. Forty-eight ambulatory women (16 per arm) 65 years and older with UUI or OAB and who screen positive for high fall risk will be randomized (1:1:1) to one of three arms. Feasibility will be determined through key milestones on evaluability, adherence to the interventions, attrition, adverse events, productive recruitment methods, and sample characteristics. We will also measure important indicators of symptom severity, quality of life, physical activity, falls, and fear of falling. Building upon our preliminary work, fall risk will be determined by the Centers for Disease Control and Prevention (CDC), Stopping Elderly Accidents, Deaths, and Injuries (STEADI) fall risk screening tool. The proposed study is the first to compare these common non-surgical treatments for UUI and OAB in a high fall risk patient population and will lay the groundwork for a program of research investigating the bidirectional relationships that exist across these two common geriatric syndromes both at the level of shared risk factors and responses to treatment.

抽象的 未经治疗的，尿的紧迫性和尿失禁会导致降低身体活动的恶性循环， 社会隔离，恐惧坠落和跌倒。小便的冲动也可能限制体育锻炼 - 关注 让自己离浴室太远可能是呆在家里的强大动力。结构 行为干预或药物是常见的初始治疗选择。但是他们引起了效果 通过截然不同的作用机制，可能会影响秋天相关结果的不同。有， 但是，关于非药物和药理学的批评缺乏直接直接的头对头试验证据 紧迫性尿失禁（UUI）的治疗方法，特别是在跌倒风险的女性中。提议 可行性试验研究是一种随机，多臂混合方法，临床试验，比较了目前正在使用的三个 老年妇女的初始治疗选择：i）一个12周结构化的基于行为的骨盆底肌肉 诊所物理治疗师进行的培训（PFMT）干预措施； ii）Beta-3的12周课程 激动剂，Mirabegron； iii）女性为12周的抗毒性抗毒性，氯化葡萄球菌的疗程65和 年龄较大的UUI或过度活跃的膀胱（OAB），他们的跌落风险增加也呈阳性。 Mirabegron 和tro氏菌与纵向对认知的影响无关，因为传统上使用的抗胆碱能 最近已经链接了调解。我们的具体目的是1）在临床环境中进行试点研究 确定在三臂摔倒的高风险的UUI或OAB的老年妇女的可行性 （PFMT，与Mirabegron vs. Trompium），随机比较有效性试验； 2）表征结果 在三种干预措施中； 3）定性探索影响非 - 的感知因素 这些患者的药理和药理治疗经验。四十八名卧床妇女（16岁 每只手臂）65岁及以上的UUI或OAB，谁将随机筛选高跌落风险的阳性 （1：1：1）到三只手臂之一。可行性将通过评估性的关键里程碑来确定 干预措施，损耗，不利事件，生产募集方法和样本特征。我们 还将衡量症状严重程度，生活质量，体育锻炼，跌倒和恐惧的重要指标 跌倒。在我们的初步工作的基础上，跌倒风险将由疾病控制中心和 预防（CDC），阻止老年人事故，死亡和伤害（Steadi）跌落风险筛查工具。这 拟议的研究是第一个在高跌落中对UUI和OAB的这些常见的非手术治疗进行比较 风险患者群体，并将为研究双向研究奠定基础 这两个常见的老年综合症之间存在的关系都处于共同风险因素水平 和对治疗的反应。